Evidence map›Paper›PMID 40399415›Full record

ArticleProstate cancer and prostatic diseases2025

Feasibility and safety study of the Flostent™ system (RAPID-I).

Dean Elterman, Ingrid Perscky, Ruben Urena, Alia Codelia-Anjum, Adam Kadlec, Bilal Chughtai

Abstract readClinical StudyMulticenter Study
In one paragraph

Article in Prostate cancer and prostatic diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Best of 2025 in prostate cancer and prostatic diseases.Prostate cancer and prostatic diseases · 2026
    Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Dean Elterman *Division of Urology, University of Toronto, Toronto, ON, Canada.ORCID 0000-0003-1507-7783
Ingrid Perscky *Department of Urology, Pacífica Salud, Hospital Punta Pacífica, Panamá, Panama.
Ruben UrenaDepartment of Urology, Pacífica Salud, Hospital Punta Pacífica, Panamá, Panama.
Alia Codelia-AnjumDepartment of Urology, Northwell Health, New York, NY, USA.
Adam KadlecRivermark Medical, Inc., Milwaukee, WI, USA.
Bilal ChughtaiDepartment of Urology, Northwell Health, New York, NY, USA. bchughtai@northwell.edu.ORCID 0000-0002-0515-2578

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study aimed to evaluate the feasibility and safety of the FloStent™, a novel nitinol prostatic stent, in men with LUTS secondary to BPH. MATERIALS AND

methodsThis multi-center, single-arm, one-year study included men aged ≥45 with BPH. Participants underwent FloStent™ implantation using a flexible cystoscope. The primary endpoints were device implantability, tolerability, and device retrievability. Secondary assessments included International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), post-void residual (PVR), and adverse events (AEs) at follow-ups over 52 weeks.

resultsThe study enrolled 15 participants with a mean age of 58.1 years. All attempts at implantation were successful. Postoperative catheterization was not required in any patient. Significant improvements were observed in IPSS and Qmax. Thirteen AEs were reported, all resolved, with no serious complications. Device retrieval was safely performed using standard urological equipment up to one-year post-implantation.

conclusionsThis preliminary study indicates that the FloStent™ is a safe and effective treatment option for BPH, providing significant symptom relief and improved urinary function with a favorable risk profile. Further research, including larger, randomized controlled trials, are needed to validate these findings and establish the long-term efficacy and safety of the FloStent™ device.

Indexed as

Lower Urinary Tract SymptomsProstatic HyperplasiaStentsAgedAlloysFeasibility StudiesHumansMaleMiddle AgedTreatment OutcomeAlloysnitinol

Identifiers

PMID40399415
PMCPMC12643913

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.